OP0165 LONG-TERM SAFETY OF BIOLOGICS VS CONVENTIONAL SYNTHETIC TREATMENTS IN SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS PATIENTS
Authors: A. I. Rebollo Giménez, L. Carlini, Y. Vyzhga, E. Alexeeva, C. Myrup, S. Magni-Manzoni, M. Trachana, V. Stanevicha, C. Ailioaie, E. Tsitsami, A. V. Cochino, C. Pallotti, S. Scala, A. Pistorio, S. Vastert, J. F. Swart, N. Ruperto
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> The better understanding of systemic Juvenile Idiopathic Arthritis (sJIA) pathogenesis and availability of new drugs, such as biologic disease-modifying anti-rheumatic drugs (bDMARDs) specifically dedicated to sJIA, have led to treatment advances that have ameliorated the disease outcome and reduced the use of glucocorticoids. However, published evidence on long term safety data regarding biologic therapies in sJIA is still limited. <h3>Objectives</h3> The objective of the study was to compare the adverse events (AEs) of at least moderate intensity and serious AEs in sJIA patients treated with biologics compared with a cohort treated with csDMARDs (conventional synthetic disease-modifying anti-rheumatic drugs) <h3>Methods</h3> Patients with sJIA, classified according to the International League of Associations for Rheumatology (ILAR), enrolled in the Pharmachild Registry since 2011 and followed up until 31 December 2022 were included. All patients had received at least one bDMARDs or csDMARDs. Those who switched to more than one treatment during the period of observation were assigned only to one group according to the longest time of drug exposure. AEs are reported according to the latest release of the Medical Dictionary for Regulatory Activities (MedDRA, Version 23.1) and were grouped into highest term "System Organ Classes" (SOCs). Frequency of SOCs were analysed. Events repeated for the same SOC in the same patient were counted once in the analysis. <h3>Results</h3> A total of 980 sJIA patients were enrolled, 353 treated with bDMARDs and 627 treated with csDMARDs. The distribution of demographic data was similar in both cohorts, with the exception that the prescription of csDMARDs compared to bDMARDs was more frequent in other continents compared to Europe. As shown in the Table 1, patients in the bDMARDs group developed more frequently infections and infestations (41.4%), skin and subcutaneous tissue disorders (11.3%) and general disorders and administration site conditions (8.2%) than patients treated with csDMARDs (all p&lt;0.0001). On the other hand, endocrine disorders were more frequent in the csDMARDs group (7.3%, p=0.03). The distribution between other SOCs was similar in children treated with bDMARDs compared with csDMARDsA. <h3>Conclusion</h3> Patients in the bDMARD group had a higher prevalence of infections and skin manifestations when compared with the csDMARDs cohort. <h3>Acknowledgements</h3> This work was partially supported by the Fundación Española de Reumatología (FER). <h3>Disclosure of Interests</h3> Ana Isabel Rebollo Giménez: None declared, Luca Carlini: None declared, Yulia Vyzhga: None declared, Ekaterina Alexeeva Speakers bureau: from Roche, Novartis and Pfizer., Grant/research support from: from Roche, Pfizer, Centocor, Eli Lilly, AbbVie, Bristol-Myers Squibb, MSD, Sanofi, Amgen and Novartis., Charlotte Myrup: None declared, Silvia Magni-Manzoni: None declared, Maria Trachana: None declared, Valda Stanevicha: None declared, Constantin Ailioaie: None declared, Elena Tsitsami: None declared, A V Cochino: None declared, Chiara Pallotti: None declared, Silvia Scala: None declared, Angela Pistorio: None declared, Sebastian Vastert Speakers bureau: from SOBI and Novartis, Grant/research support from: Institutional Grant from SOBI in a privat-public grant opportunity of ZonMW, Joost F. Swart: None declared, Nicolino Ruperto Speakers bureau: NR has received honoraria for consultancies or speaker bureaus from the following pharmaceutical companies in the past 3 years: 2 Bridge, Amgen, AstraZeneca, Aurinia, Bayer, Brystol Myers and Squibb, Celgene, inMed, Cambridge Healthcare Research, Domain Therapeutic, EMD Serono, Glaxo Smith Kline, Idorsia, Janssen, Eli Lilly, Novartis, Pfizer, Sobi, UCB., Grant/research support from: The IRCCS Istituto Giannina Gaslini (IGG), where NR works as full-time public employee has received contributions from the following industries in the last 3 years: Bristol Myers and Squibb, Eli-Lilly, F Hoffmann-La Roche, Novartis, Pfizer, Sobi. This funding has been reinvested for the research activities of the hospital in a fully independent manner, without any commitment with third parties.